Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
Phase 1
- Conditions
- Healthy Volunteers
- Registration Number
- NCT00347815
- Lead Sponsor
- Danish University of Pharmaceutical Sciences
- Brief Summary
The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
healthy 18-40 years able to follow the protocol able to provide informed consent
Exclusion Criteria
- Allergy to buprenorphine
- Mental illness
- Alcohol or drug abuse
- Chronic pain
- Daily use of analgesics
- Chronic medicinal treatment
- Treatment with corticosteroids
- Any use of medicine 48 hours before day of trial
- Smoker
- Blood donation within 3 months before day of trial
- Dementia
- Abnormal ECG
- Abnormal blood values:
Serum creatinine > 100 umol/l Serum haemoglobin < 8 mmol/L LDH < 105 U/L or > 255 U/L ASAT > 45 U/L ALAT > 70 U/L PP < 0.9 INR or > 1.1 INR Alkaline phosphatase < 35 U/L or > 275 U/L K+ < 3,5 mmol/L or > 5,0 mmol/L Na + < 136 mmol/L or > 146 mmol/
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gentofte University Hospital
🇩🇰Hellerup, Denmark